Sorrento Therapeutics, Inc. (NASDAQ: SRNE, "Sorrento") announced
that the company has received FDA clearance to proceed with a
global Phase 2 clinical study of resiniferatoxin (RTX), entitled “A
Multicenter, Phase 2 Study to Assess the Safety and Efficacy of
Epidural Resiniferatoxin for the Treatment of Intractable Pain
Associated with Advanced Cancer”. The Phase 2 trial, a
multi-center, double blind, controlled study will assess the
“efficacy and safety of several RTX doses vs. placebo controls to
manage intractable pain in up to 120 patients with advanced cancer”
(NCT05067257). Three RTX dose groups (15, 20 and 25 mcg) will be
evaluated against both a vehicle control group and a concurrent
control group over a year of follow up. The primary objective of
the study is to identify the recommended Phase 3 dose for later
studies.
The decisions related to this indication follow
the analysis of the significant observations from the Phase 1b
trial results (NCT03226574). The Phase 1 was an ascending dose
safety study in 17 patients to assess the safety and preliminary
efficacy of epidural administration of resiniferatoxin for the
treatment of intractable pain due to cancer. RTX was generally well
tolerated after epidural administration at doses up to 30 mcg with
the most common adverse event of “procedural pain” experienced by
just over half of subjects (52.9%) and all of these events were
considered at most moderate severity and lasted only a few hours.
Pharmacokinetic sampling showed no measurable systemic RTX levels
in nearly all subjects. Preliminary efficacy showed promising
long-standing benefit in pain reduction.
In the Phase 1 study, clinical efficacy was
defined as a 30% decrease in average pain scores (CE30), calculated
for both average pain for three consecutive days from original
baseline score of ≥ 6 on a scale of 1 to 10 (NRS rating scale) and
worst average pain, compared to baseline using the NRS during the 3
months post injection. Eleven of 17 subjects achieved this efficacy
endpoint with subjects receiving 15 or 25 mcg showing the best
results. For CE50 and CE70, 6 and 4 subjects, respectively,
achieved these endpoints again with those receiving 15 or 25 mcg
showing best results. These results are promising in view of the
challenging, intractable pain conditions due to advanced cancer,
however the somewhat small sample size enrolled requires
confirmation in larger follow-on studies.
About Resiniferatoxin (RTX)
Resiniferatoxin is a small-molecule derivative
(diterpene ester), purified from a cactus-like plant (Euphorbia
sp.). It is a highly potent agonist of the transient receptor
potential vanilloid-1 (TRPV1) receptor which are specifically
upregulated with chronic severe noxious pain. A thousand times
“hotter” than pure capsaicin (16 billion Scoville units versus 16
million), and with a high affinity for afferent sensory pain
nerves, resiniferatoxin binds to TRPV1 receptors and selectively
ablates the neurons responsible for perpetuating chronic severe
pain signals experienced by patients.
More information on this trial can be found at
www.clinicaltrials.gov (NCT03542838).
About Sorrento Therapeutics, Inc.
Sorrento is a clinical and commercial stage
biopharmaceutical company developing new therapies to treat cancer,
pain (non-opioid treatments), autoimmune disease and COVID-19.
Sorrento's multimodal, multipronged approach to fighting cancer is
made possible by its extensive immuno-oncology platforms, including
key assets such as fully human antibodies (“G-MAB™ library”),
immuno-cellular therapies (“DAR-T™”), antibody-drug conjugates
(“ADCs”), and oncolytic virus (“Seprehvec™”). Sorrento is also
developing potential antiviral therapies and vaccines against
coronaviruses, including Abivertinib, COVIGUARD™, COVI-AMG™,
COVISHIELD™, COVI-MSC™ and COVIDROPS™; and diagnostic test
solutions, including COVITRACK™, COVISTIX™ and COVITRACE™.
Sorrento's commitment to life-enhancing
therapies for patients is also demonstrated by our effort to
advance a first-in-class (TRPV1 agonist) non-opioid pain management
small molecule, resiniferatoxin (“RTX”), and SP-102 (10 mg,
dexamethasone sodium phosphate viscous gel) (SEMDEXA™), a novel,
viscous gel formulation of a widely used corticosteroid for
epidural injections to treat lumbosacral radicular pain, or
sciatica, and to commercialize ZTlido® (lidocaine topical system)
1.8% for the treatment of post-herpetic neuralgia. RTX has
completed a Phase 1b trial for intractable pain associated with
cancer and a Phase 1b trial in osteoarthritis patients. SEMDEXA is
in a pivotal Phase 3 trial for the treatment of lumbosacral
radicular pain, or sciatica. ZTlido® was approved by the FDA on
February 28, 2018.
For more information visit
www.sorrentotherapeutics.com.
Forward-Looking Statements
This press release and any statements made for
and during any presentation or meeting contain forward-looking
statements related to Sorrento Therapeutics, Inc., under the safe
harbor provisions of Section 21E of the Private Securities
Litigation Reform Act of 1995 and subject to risks and
uncertainties that could cause actual results to differ materially
from those projected. Forward-looking statements include statements
regarding the expectations for Sorrento's and its subsidiaries'
technologies and product candidates, including, but not limited to,
resiniferatoxin (RTX), the clinical potential of RTX, including its
potential efficacy and the potential for RTX to address long-term
control refractory cancer pain in a broad spectrum of patients,
RTX’s potential to reduce or completely eliminate pain and/or the
need for high dose opioids in advanced cancer patients, timing for
commencing additional Phase 2 and/or 3 clinical trials for RTX, and
the possibility of proceeding to a Phase 3 trial. Risks and
uncertainties that could cause our actual results to differ
materially and adversely from those expressed in our
forward-looking statements, include, but are not limited to: risks
related to Sorrento's technologies and prospects, including, but
not limited to risks related to seeking regulatory approval for
RTX; clinical development risks, including risks in the progress,
timing, cost, and results of clinical trials and product
development programs; risk of difficulties or delays in obtaining
regulatory approvals; risks that clinical study results may not
meet any or all endpoints of a clinical study and that any data
generated from such studies may not support a regulatory submission
or approval; risks that prior test, study and trial results may not
be replicated in future studies and trials; risks of manufacturing
and supplying drug product; risks related to leveraging the
expertise of its employees, subsidiaries, affiliates and partners
to assist Sorrento in the execution of its therapeutic antibody
product candidate strategies; risks related to the global impact of
COVID-19; and other risks that are described in Sorrento's most
recent periodic reports filed with the Securities and Exchange
Commission, including Sorrento's Annual Report on Form 10-K for the
year ended December 31, 2020, and subsequent Quarterly Reports on
Form 10-Q filed with the Securities and Exchange Commission,
including the risk factors set forth in those filings. Investors
are cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date of this release and we
undertake no obligation to update any forward-looking statement in
this press release except as required by law.
Media and Investor Relations
ContactAlexis Nahama, DVM (SVP Corporate
Development)Email: mediarelations@sorrentotherapeutics.com
Sorrento® and the Sorrento logo are registered
trademarks of Sorrento Therapeutics, Inc.
G-MAB™, DAR-T™, SOFUSA™, COVIGUARD™, COVI-AMG™,
COVISHIELD™, COVIDROPS™, COVI-MSC™, COVITRACK™, COVITRACE™ and
COVISTIX™ are trademarks of Sorrento Therapeutics, Inc.
SEMDEXA™ is a trademark of Semnur
Pharmaceuticals, Inc.
ZTlido® is a registered trademark owned by
Scilex Pharmaceuticals Inc.
All other trademarks are the property of their
respective owners.
©2021 Sorrento Therapeutics, Inc. All Rights
Reserved.
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